Integrated Experiential Training Program With Coaching by Nursing Students in Childhood Cancer Patients

NCT ID: NCT02754973

Last Updated: 2018-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2017-11-30

Brief Summary

Background: Despite the evidence that regular physical activity can have beneficial effects on the physical and psychological well-being of cancer patients, a review of the literature reveals that a majority of young cancer patients fail to attain the same levels of physical activity that they had before contracting the disease. There is scientific evidence that physical inactivity induces muscle catabolism and atrophy and cardiovascular diseases, which may lead to a further increase in fatigue and a decrease in the functional capacity of cancer patients. Empirical evidence is needed to explore an appropriate strategy for promoting physical activity in such patients.

Purposes: To examine the effectiveness of an integrated experiential training program with coaching by nursing students in promoting regular physical activity, reducing fatigue and enhancing quality of life among Hong Kong Chinese childhood cancer patients.

Design and Subjects: A randomised controlled trial (RCT), two-group pre-test and repeated post-test, within and between subjects design will be conducted. Recruitment of subjects will be carried out in a paediatric oncology ward of a Hong Kong acute care hospital.

Intervention: Participants in the experimental group will join an integrated experiential training program with coaching by nursing students, which contains 28 home visits by a designated nursing student as a coach for a 6-month period. Those in the placebo control group will receive an amount of time and attention (home visits by research assistants) that mimics that received by the experimental group.

Detailed Description

The aim of this study is to examine the effectiveness of an integrated experiential training program with coaching by nursing students in promoting regular physical activity, reducing fatigue and enhancing quality of life among Hong Kong Chinese childhood cancer patients.

Intervention

Experimental group

During hospitalization for cancer treatment, besides receiving usual care, a registered nurse will deliver participants a health education talk. Participants will then be taught and encouraged to practice some simple stretching and relaxing exercises. After discharged from the hospital, participants in the experimental group are scheduled to take part in an integrated experiential training program with coaching by nursing students. Each participant is allocated to a nursing student who was voluntarily trained as coaches for the program. The intervention is implemented to each participant by the designated coach during 28 home visits throughout a 6-month period (24 weeks) and each visit lasts for about 1 hour. The 1-hour program consists of a 30-minute English tutorial session, and a 30-minute physical activity session with the coach. The same coach pays a visit to a participant at twice a week for the first 4 weeks and then once a week for the subsequent 20 weeks. During the individual coaching sessions with the young people, the coaches will teach and demonstrate physical activities in 4 levels to the participants according to participants' ability.

Placebo control group

Since participants in both groups are hospitalized in the same unit, to avoid contamination, participants in the placebo control group will receive the same intervention as those participants in the experimental group during their hospitalization. When discharged home, participants will receive an amount of time and attention (home visits by research assistants) that mimicked that received by the experimental group, but which is thought not to have any specific effect on the outcome measures. The activities during the home visits over a six-month period include playing cards or chess games, health advice on the prevention of influenza and healthy diet which will be conducted for 30 minutes.The participants will also receive a 30-minute English tutorial session with the research assistants in each home visit.

To ensure the dosage of intervention delivered in terms of the amount, frequency, duration, and breadth would be adequate to assess physical activity levels, physical activity self-efficacy, cancer-related fatigue, depression, muscle strength, and quality of life, a research committee is crucial to assess the dosage of the intervention and to train the volunteer nursing students as coaches for the intervention. In particular, the safety and appropriateness of the intervention content were reviewed carefully by the committee before commencement. The members in the committee consist of an associate professor, an assistant professor and a research student from a local university who are equipped with extensive experience in conducting different research and particularly, psychosocial interventions for children with cancer. The committee also includes a professor in paediatric oncology and a specialist nurse with substantial experience in delivering care to children undergoing cancer treatment, and an assistant professor who is an expert specialising in sports and recreation management.

Data Collection Methods

Approval for the study was obtained from the hospital ethics committees. To identify potential subjects, the research student approach to eligible children and their parents after screening the medical records in a paediatric oncology ward of a public acute care hospital in Hong Kong. After explaining the study details, including its purpose, procedures and potential harms and benefits, parents allowing their children to take part are required to sign a consent form. In addition, the children who are going to participate are invited to write down their names on a specially designed child assent form and told that their participation is voluntary.

Data collection for the outcome variables is conducted at the time of the subject recruitment (T1), and six (T2), and nine (T3) months after the start of the intervention, except that physical activity levels of childhood cancer patients are collected at the time of the subject recruitment (T1), and nine (T2) months after the start of the intervention. Before randomisation, participants are required to complete the hand grip strength test with the hand-held dynamometers (HHD) and fill in a set of questionnaires including CUHK-PARCY, the Chinese versions of PA-SE, fatigue scale, CES-DC, and PedsQL cancer module. Semi-structured interviews will also be carried out.

Analysis

The Statistical Package for Social Sciences (SPSS) software, version 21.0 for Windows will be used to analyze quantitative data. Intention-to-treat analysis will be used and missing data will be substituted by the last-observation-carried-forward procedure. The comparability of the experimental and control groups will be assessed by using inferential statistics (independent t-test and chi-squared test). Descriptive statistics will be used to calculate the mean scores and standard deviation of different scales. Mixed between-within subjects ANOVA (split-plot ANOVA) and post-hoc analysis using the Tukey procedure will be used to determine whether the integrated experiential training program with coaching by nursing students was effective in reducing fatigue, increasing childhood cancer patients' levels of physical activity, self-efficacy and muscle strength, decreasing depressive symptoms and enhancing their quality of life. Descriptive phenomenology will be employed during the process of qualitative data analysis.

Conditions

Child; Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Experimental group

During hospitalization for cancer treatment, besides receiving usual care, participants in the experimental group will first receive a health education talk Participants will then be taught and encouraged to practice with some stretching and relaxing exercises during their hospitalization. After hospitalization, participants will receive an integrated experiential training program with coaching by nursing students through home visits.

Group Type: EXPERIMENTAL

an integrated experiential training program with coaching

Intervention Type: BEHAVIORAL

The intervention will be implemented to each participant by a designated coach who is a trained nursing student during 28 home visits throughout a 6-month period (24 weeks) and each visit will last for about 1 hour. The 1-hour program consists of a 30-minute English tutorial session, and a 30-minute physical activity session with the coach. The same coach will pay a visit to a participant at twice a week for the first 4 weeks and then once a week for the subsequent 20 weeks. 4 levels of physical activity will be taught to the participants gradually according to their ability.

Placebo Control group

Since participants in both groups are hospitalized in the same unit, to avoid contamination, participants in the placebo control group will receive the same intervention as those participants in the experimental group during their hospitalization. When discharged home, participants will receive an amount of time and attention (home visits by research assistants) that mimicked that received by the experimental group, but which is thought not to have any specific effect on the outcome measures.

Group Type: PLACEBO_COMPARATOR

Placebo Control

Intervention Type: BEHAVIORAL

When discharged home, participants will receive an amount of time and attention (home visits by research assistants) that mimicked that received by the experimental group, but which is thought not to have any specific effect on the outcome measures. The placebo activities during the home visits may include playing cards or chess games, health advice on the prevention of influenza and healthy diet which will be conducted for 30 minutes.The participants will also receive a 30-minute English tutorial session with the research assistants in each home visit.

Interventions

an integrated experiential training program with coaching

The intervention will be implemented to each participant by a designated coach who is a trained nursing student during 28 home visits throughout a 6-month period (24 weeks) and each visit will last for about 1 hour. The 1-hour program consists of a 30-minute English tutorial session, and a 30-minute physical activity session with the coach. The same coach will pay a visit to a participant at twice a week for the first 4 weeks and then once a week for the subsequent 20 weeks. 4 levels of physical activity will be taught to the participants gradually according to their ability.

Intervention Type: BEHAVIORAL

Placebo Control

When discharged home, participants will receive an amount of time and attention (home visits by research assistants) that mimicked that received by the experimental group, but which is thought not to have any specific effect on the outcome measures. The placebo activities during the home visits may include playing cards or chess games, health advice on the prevention of influenza and healthy diet which will be conducted for 30 minutes.The participants will also receive a 30-minute English tutorial session with the research assistants in each home visit.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• aged between 9 to 18
• diagnosed with cancer at some time in the previous month and currently undergoing active treatments
• able to speak Cantonese and read Chinese

Exclusion Criteria

• evidence of recurrence or second malignancies
• physical impairment or cognitive or learning problems identified from their medical records

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ho Cheung William Li

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

The University of Hong Kong

Hong Kong, , China

Countries

China

References

Lam KKW, Li WHC, Chung OK, Ho KY, Chiu SY, Lam HS, Chan GCF. An integrated experiential training programme with coaching to promote physical activity, and reduce fatigue among children with cancer: A randomised controlled trial. Patient Educ Couns. 2018 Nov;101(11):1947-1956. doi: 10.1016/j.pec.2018.07.008. Epub 2018 Jul 7.

Reference Type: DERIVED

PMID: 30007765 (View on PubMed)

Other Identifiers

UW15-219

Identifier Type: -

Identifier Source: org_study_id